Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine

NCT01944423 | Completed Early Phase 1 Results

• 1 other identifier: R34DA034658
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting treatment of smoking cessation for individuals with panic attacks. The investigators hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence greater smoking abstinence rates and decreased panic symptoms after receiving a combined CBT-based treatment for smokers with panic attacks.

Conditions

Nicotine Addiction; Panic Attack

Outcome Measures

Primary Outcomes (1)

• Smoking Abstinence

  Smoking status will be assessed at baseline and each of the follow-up assessments using point prevalence abstinence (PPA) measures verified with carbon monoxide and saliva cotinine.

  Assessed from week 3-29, week 29 reported

Secondary Outcomes (2)

• Anxiety Sensitivity Mechanistic Target

  Assessed from week 3-29, week 7 reported (end of treatment)

• Panic Symptoms Mechanistic Target

  Assessed from week 3-29, week 29 reported (6-month follow-up)

Study Arms (2)

PSRT_DCS

EXPERIMENTAL

Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).

Drug: d-cycloserine; Drug: Nicotine replacement therapy; Behavioral: Panic and Smoking Reduction Treatment

PSRT_PBO

PLACEBO COMPARATOR

Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).

Drug: Pill Placebo; Drug: Nicotine replacement therapy; Behavioral: Panic and Smoking Reduction Treatment

Interventions

d-cycloserine DRUG

d-cycloserine is a medication thought to be associated with fear extinction.

Also known as: d-cycloserine; DCS

PSRT_DCS

Pill Placebo DRUG

Also known as: sugar pill

PSRT_PBO

Nicotine replacement therapy DRUG

All participants will receive Nicoderm CQ®, 24-hour transdermal nicotine patches and will be educated about the use of the patch at the session immediately prior to quit date. They will be instructed to apply one patch daily, beginning on quit date (week 5). Participants will use the 3-step tapering Nicoderm process (21-mg, 14-mg, and 7-mg). This regimen has been used in previous trials with a similar formulation of the patch (Fiore, 2000). A meta-analysis found no differences in outcome between 16- or 24-hour patches (Fiore et al., 1994). Participants who continue to smoke or lapse after quit day will not be instructed to discontinue the patch until their smoking level reaches 4 cigarettes/day for 4 days. Smokers who lapse during treatment will be encouraged to set a new quit date and continue their cessation attempt.

Also known as: patch, NRT, nicoderm,

PSRT_DCS; PSRT_PBO

Panic and Smoking Reduction Treatment BEHAVIORAL

PSRT incorporates elements of standard smoking cessation treatment (i.e., counseling plus NRT) with procedures for reducing panic and enhancing tolerance to withdrawal sensations. Written therapist and patient manuals will be used and followed at all times to ensure standardized delivery of the treatment. Interventions that uniquely focus on addressing panic, fears and intolerance of anxiety, bodily-related sensations, and affect-relevant withdrawal symptoms include: (1) interoceptive exposure; (2) corrective information about anxiety and cognitive interventions designed to teach patients alternatives to catastrophic misinterpretations of the sensations and their feared consequences; and (3) situational exposure.

Also known as: PSRT, CBT, cognitive behavioral therapy, panic reduction, smoking cessation

PSRT_DCS; PSRT_PBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ages 18-65 capable of providing informed consent
• Willing and able to provide informed consent, attend all study visits and comply with the protocol
• Daily smoker for at least one year
• Currently smoke an average of at least 8 cigarettes per day
• Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
• Evidence of panic attack within the past year and endorsement of smoking as an emotion regulation strategy (i.e., score at least a 78 on the SAEQ).

You may not qualify if:

• Subjects who do not use smoking as an emotion regulation strategy
• Current diagnosis of a psychotic, eating, developmental or bipolar disorder
• Significant suicide risk as determined by structured interview
• Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
• Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
• Current use of isoniazid or ethionamide compounds
• A history of significant medical condition and/or be deemed as currently unhealthy in the context of a complete physical examination
• Limited mental competency and the inability to give informed, voluntary, written consent to participate
• Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
• Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study
• Use of other tobacco products
• Plans to move outside of the immediate area in the next six months
• Insufficient command of the English language

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Smits JAJ, Zvolensky MJ, Otto MW, Piper ME, Baird SO, Kauffman BY, Lee-Furman E, Alavi N, Dutcher CD, Papini S, Rosenfield B, Rosenfield D. Enhancing panic and smoking reduction treatment with D-Cycloserine: A pilot randomized clinical trial. Drug Alcohol Depend. 2020 Mar 1;208:107877. doi: 10.1016/j.drugalcdep.2020.107877. Epub 2020 Jan 22.

  PMID: 32004998 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Panic Disorder

Interventions

Cycloserine; Sugars; Nicotine Replacement Therapy; Transdermal Patch; Nicotine; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates; Drug Therapy; Therapeutics; Equipment and Supplies; Solanaceous Alkaloids; Alkaloids; Pyridines; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Jasper Smits
• Organization: Univeristy of Texas at Austin

smits@utexas.edu

512-475-8095

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 17, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-05

Locations

US (1)